NCT02123017

Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy

An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.

Conditions

• Colonoscopy Preparation

Interventions

Type	Name	Description
DRUG	90 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
DRUG	135 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
DRUG	180 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-25
• Last updated: 2016-02-24
• Results posted: 2016-02-24

Locations

1 site across 1 country: United States